Randomized Clinical Study for Pharmacokinetics and Pharmacodynamics Assessment of Drug Eritromax, Marketed by the Blausiegel Laboratory, Compared to Drug Eprex, Produced by Janssen-Cilag Laboratory, in Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pharmacokinetic - rHuEPO concentration.
研究概览
简要总结
The epoetin is a glycoprotein and endogenous hormone, which is primarily synthesized by specific epithelial cells lining the kidney peritubular capillaries, and regulates continuous formation of red blood cells. This is a pharmacokinetics and pharmacodynamics study, in which each subject will receive the investigational product in different periods, as randomisation (Teste or Comparator). The evaluation of the profile included serum dosage of medications and reticulocyte count in peripheral blood.
详细描述
This a prospective randomized and crossover study for evaluation of pharmacokinetics and pharmacodynamics of two epoetins formulations. The subjects will receive in each confinement period 4000 IU one of the investigational product subcutaneously, according to randomisation, separated by a washout period of 4 weeks. The evaluation of the profile between products included serum dosage of medications and reticulocyte count in peripheral blood. Safety evaluation data will include report od all adverse events (including type, frequency, intensity, seriousness, severity and action taken related to the investigational product study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Confirm the voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
- •Being male, aged between 20 and 55 years, clinically healthy;
- •BMI between 18 and 25;
- •Results of examination of hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
- •Results of VCM, HBMC, platelets and leukocytes within the normal range:
- •VCM = Between 82 to
- •Among the HBMC = 26 to
- •Among the platelets = 150,000 to 400,000 units per mL. Among the WBC = 3,500 to 10,500 units per mL and without cellular atypia.
- •Serum ferritin = Male between 36 to 262 mcg / L and women between 24 to 155 mcg / L;
- •Reticulocyte count in peripheral blood ≤ 3%;
- •Serum erythropoietin less than 30 mIU / mL.
排除标准
- •Participation in clinical trials in the 12 months preceding the survey;
- •Presence of iron deficiency anemia;
- •Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
- •Acute disease in the period of 07 days prior to inclusion;
- •Chronic administration of medication to determine, such as high blood pressure;
- •Hormone therapy in the period of 02 months prior to inclusion;
- •Administration of any drug in the 02 weeks prior to inclusion;
- •A history of autoimmune anemia or hereditary;
- •research subjects with a history of chronic bleeding;
- •research subjects with a history of acute bleeding in the last 30 days;
- •History of sensitivity to biological products derived from mammals, albumin, or any component of the formulation;
- •History of or current use at least 12 months of tobacco;
- •Current or previous history (less than 12 months) of illicit drug use;
- •previous therapy with erythropoietin;
- •albumin below 3.5 g / dl or greater than 4.8 g / dL;
- •Signs or clinical history of bone marrow aplasia;
- •History of liver disease and clinical or laboratory;
- •History of renal disease and clinical or laboratory.
研究组 & 干预措施
Test ERITROMAX
Blausiegel Industria e Comercio Ltda. Recombinant Human Erythropoietin (ERITROMAX)
干预措施: Eritromax (Drug)
EPREX
Janssen-Cilag Recombinant Human Erythropoietin (EPREX)
干预措施: Eprex (Drug)
结局指标
主要结局
Pharmacokinetic - rHuEPO concentration.
时间窗: Before administration (Time 0 hour) and after time 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 11 hours, 12 hours, 13 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours and 120 hours administration.
Will evaluated through the plasma rHuEPO dosage before and after drug administration.
Pharmacodynamics - Absolute Reticulocyte Count.
时间窗: Before administration (Time 0 hour) and after Time 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours, 240 hours and 576 hours administration.
Will evaluated through the absolute reticulocyte count at total blood.
次要结局
未报告次要终点
研究者
Azidus Brasil
Principal Investigator Alexandre Frederico
Azidus Brasil